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ICON plc · 3 months ago

Senior Regulatory Affairs Project Manager I

Austin, TX

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

ICON is seeking a highly motivated and dedicated Project Manager to work at the intersection of structural design and testing, overseeing the testing process for validation and regulatory acceptance of ICON's breakthrough 3D-printed structural systems and materials. This role is responsible for directing the validation and acceptance efforts, ensuring target schedules and budgets are achieved while collaborating with external consultants and testing laboratories.

Biotechnology

H1B Sponsor Likely

Responsibilities

Develop and manage project schedules, cost estimates, and budgets for complex testing campaigns while tracking progress against milestones and managing scope changes

Direct and oversee comprehensive test plan development and specimen design that meets structural testing objectives and regulatory requirements for ICON's 3D printed systems

Develop and oversee the generation of detailed engineering documentation for print processes such as technical drawings, instructions, and logs, directing team members and consultants as needed

Coordinate with internal ICON departments including Testing, Hardware, and Operations teams to ensure testing is successfully completed while communicating project progress, blockers, and results to key stakeholders

Manage and oversee contracts with third-party laboratories, consultants, and vendors conducting advanced analysis, research, development, or manufacturing for ICON to ensure successful execution of the regulatory program goals and objectives. Including but not limited to testing logistics, shipping, proposal evaluation, cost negotiation, schedule coordination, performance oversight, and deliverable management

Participate in testing observations and coordinate with external stakeholders to gather real-time data while directing project teams and resolving scheduling conflicts

Conduct and oversee the analysis and interpretation of test results using advanced analytical techniques, guiding consultants and team members in identifying performance trends and developing design methodologies

Provide regular updates on project progress to the Regulatory Affairs Program Manager, and Director of Building + Construction Science

Support regulatory approval processes by directing established testing approaches, guiding development of new methodologies, and overseeing preparation of comprehensive technical documentation for regulatory bodies in accordance with the project schedule and budget

Qualification

Structural EngineeringRegulatory Approval ProcessesProject ManagementTechnical DocumentationConcrete TestingAnalytical Skills3D Printing TechnologiesTechnical WritingCommunication SkillsProblem-Solving Skills

Required

Graduate degree in Civil Engineering, Structural Engineering, or a related technical discipline

8+ years of relevant professional experience in structural design, testing, research, or construction with demonstrated project management responsibilities

Demonstrated experience managing multiple concurrent complex technical projects, including schedule development, budget management, and stakeholder coordination

Proven ability to work with and manage external consultants, laboratories, and vendors while maintaining quality standards and project deliverables

Strong understanding of structural engineering from first principles, including mechanics of materials, structural analysis, and design fundamentals

Practical experience in the design and testing of concrete and masonry structural systems and materials

Hands-on experience with structural testing equipment, including hydraulic cylinders, pumps, actuators, load frames, instrumentation, and data acquisition systems

Advanced problem-solving abilities and analytical thinking skills to assess complex technical challenges and develop effective solutions across multiple disciplines

Strong technical writing and communication skills with demonstrated ability to prepare comprehensive reports and present findings to diverse stakeholder groups

Familiarity with applicable structural testing standards, ACs, and codes, including ASTM, ACI, ASCE, and building code requirements

Field work and overnight travel is required

Preferred

Professional Engineer (PE) license or eligibility to obtain PE licensure within 6 months of hire

Experience working with government agencies or regulatory bodies in technical approval processes

Understanding of concrete material science, including mix design, curing processes, fresh and hardened properties, and durability characteristics

Field construction experience, particularly with concrete and masonry construction methods, quality control processes, and construction tools

Experience with seismic loading analysis, seismic design code requirements, and seismic testing methodologies

Familiarity with 3D printing technologies, additive manufacturing processes, or advanced construction methods

Company

ICON plc

Glassdoor3.7

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.

Founded in 1990

Dublin, IE

10001+ employees

http://www.iconplc.com

H1B Sponsorship

ICON plc has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (4)

2024 (4)

2023 (5)

2022 (11)

2021 (4)

2020 (5)